Kornimate/medical-research-clean huggingface dataset:
cortisol augmentation of a psychological treatment in warfighters with post traumatic stress disorder (ptsd)

Conditions: PTSD

Summary: this study seeks to examine the efficacy of hydrocortisone administration in the augmentation of the therapeutic effects of prolonged exposure (pe) therapy, an empirically tested treatment shown to be effective in the the treatment of posttraumatic stress disorder (ptsd). the augmentation builds on both the translation of neuroscience findings demonstrating the effects of glucocorticoids (gcs) on learning, and on empirical clinical findings from other investigators demonstrating beneficial effects of gcs in reducing traumatic memories in trauma-exposed persons.


Eligibility criteria:
inclusion criteria: * a primary diagnosis of chronic ptsd according to diagnostic and statistical manual of mental disorders, fourth edition (dsm-iv) diagnostic criteria, resulting from a deployment-related traumatic event, and a minimum ptsd severity of 50 (caps). * the veteran must either be unmedicated or on a stable psychotropic regimen (i.e., 1 or more months on the same regimen). exclusion criteria: * lifetime history of psychotic disorder, bipolar disorder, or obsessive compulsive disorder. * moderate or severe traumatic brain injury (tbi). * a medical or mental health problem other than ptsd that requires immediate clinical attention. * substance abuse or dependence within the last 3 months. * suicidal risk (as determined by response of 5 or 6 on the suicidality items of the montgomery asberg depression rating scale (madrs)) and/or assessed suicide risk on the basis of clinical judgment. * persons on a psychotropic medication regimen that has not been consistent for one month. * presence of diabetes mellitus or any current unstable medical illness or condition that represents a contraindication to taking glucocorticoids (this will be determined by history and/or abnormal laboratory findings at medical clearance). * unwillingness to discontinue other specialized psychotherapy for ptsd during the 10 weeks of study treatment and the 6 week follow-up. (self-help (non-trauma focused) groups or supportive counseling can be continued but not initiated.) * pregnant women or those planning to become pregnant within the study period will not be enrolled. female participants must agree to use an effective method of birth control (i.e., oral contraceptive, norplant, diaphragm, condom, or spermicide, abstinence) during the course of the study to ensure they do not become pregnant during the course of the study.
comparison of different cardiac output measurement methods in patients undergoing right heart catheterization

Conditions: Pulmonary Hypertension

Summary: the objective of this observational study is to compare cardiac output evaluation by the direct fick method, indirect fick method and thermodiluition in pulmonary hypertension (ph) patients undergoing right heart catheterization (rhc). the main questions it aims to answer are: * are these methods interchangeable? * can possible discrepancies influence risk stratification and therapeutic management of ph patients? all consecutive patients aged ≥18 years, referred for rhc for suspected ph, will be included. exclusion criteria will be contraindications to rhc, cardiac shunts and failure to obtain informed consent. patients will undergo rhc by a swan-ganz catheter through the right internal jugular vein ultrasound-guided cannulation and cardiac output will be calculated using the three above-mentioned methods.


Eligibility criteria:
inclusion criteria: * age ≥18 years * suspected pulmonary hypertension at clinical and echocardiographic evaluation exclusion criteria: * contraindication to right heart catheterization (rhc) * cardiac shunt * inability to provide informed consent
feasibility of a one-day-and-a-half for patients with low back pain

Conditions: Subacute or Chronic Low Back Pain

Summary: the purpose of this study was to assess the feasibility of a one-day-and-a-half no intensive multidisciplinary education and exercise therapy program in the subgroup of patients with subacute or chronic lbp for whom first-line treatments had failed but for whom an intensive multidisciplinary rehabilitation program was not indicated.

retrospectively, data of patients between 18 and 60 years who had benefited in the pmr unit of cochin' hospital of a one-day-and-a-half no intensive multidisciplinary education and exercise therapy program are collected. this no intensive multidisciplinary education and exercise therapy program is proposed by the pmr unit of cochin' hospital to all patients with a subacute or chronic low back pain for whom first-line treatments had failed but for whom an intensive multidisciplinary rehabilitation program is not indicated. it is done in group of 4 to 6 people, performed by medical doctors with experience in the management of patients with low back pain, physiotherapists, occupational therapists, and psychologist. data regarding feasibility of this program were recorded with autoquestionnaires that patients had to fill in during the program and 3 months after.

Eligibility criteria:
inclusion criteria: * age ≥ 18 years * subacute or chronic non-specific lbp ≥ 6 weeks * no indication for an intensive multidisciplinary rehabilitation program according to the senior physician, a specialist in physical medicine and rehabilitation and/or rheumatology with a strong experience in the care of patients with non-specific lbp * currently working * written consent exclusion criteria: * inability to speak or read french * cognitive impairment * current sick leave * history of intensive multidisciplinary rehabilitation program for lbp

Keywords: multidisciplinary education and exercise therapy program. physical activity rehabilitation
soft tissue tenderness and fibromyalgia among schizophrenia patients.

Conditions: Fibromyalgia; Schizophrenia

Summary: numerous studies reported on comorbidity of fibromyalgia and psychiatric disorders. approximately 30% of patients with fibromyalgia have major depression at the time of diagnosis; the lifetime prevalence of depression is 74% and that of an anxiety disorder is 60%. in some fibromyalgia patients, mood and cognitive problems are much more prominent than tenderness. from the psychiatric point of view, 49% of ptsd patients and 5% of major depression patients fulfill criteria for diagnosing fibromyalgia. the association between schizophrenia and fibromyalgia is still unknown. study hypothesis schizophrenia patients, who have an aberrant sensation of pain, have lower prevalence of fm compared to the general population. primary objectives 1. demonstrate that schizophrenia patients have lower prevalence of fm, compared to the general population. 2. to compare the self-reported extent and intensity of pain with selected tender points examination.


Eligibility criteria:
inclusion criteria: * women above 18 years of age. * patients must meet dsm-5 criteria for a diagnosis of schizophrenia. * a stabled mental state. * if hospitalized, patients are scheduled for discharge on the basis of clinical assessment of psychiatric symptoms. exclusion criteria: * mental co-morbidity. * diagnosis of myofascial pain syndrome or chronic fatigue syndrome. * alcohol or drug use. * usage of any pain reliever medications during the week before recruitment.
the efficacy of pregabalin on the duration of the spinal anesthesia and the early postoperative pain after total knee arthroplasty

Conditions: Anesthesia

Summary: the purpose of this study is to evaluate the effectiveness of administration of pregabalin 2 hours preoperatively on the onset and the duration of the spinal anesthesia in total knee arthroplasty and the role of pregabalin in postoperative analgesia.


Eligibility criteria:
inclusion criteria: * the ages of 40 and 70 years * height 155-170 cm * american society of anesthesiologists grade i or ii . * patients underwent total knee arthroplasty under spinal anesthesia exclusion criteria: * patients known to be allergic to any medicines. * patients had a history of drug or alcohol abuse. * patients were taking opioids or sedative medications, * patients inability to communicate with investigators to evaluate the postoperative pain * patients were in need for postoperative icu hospitalization . * patients had a history of psychiatric conditions. * patients with a history of taking pregabalin or gabapentin .
intravenous chemotherapy and plant-based dietary supplements

Conditions: Breast Cancer

Summary: more and more patients report taking dietary supplements based on herbal medicine, aromatherapy, vitamintherapy,... in the course of their detoxifying anticancer chemotherapy, to stimulate the immune defenses, to relieve and/or decrease the side effects of chemo or even to act against cancer. at european level, there are between 15 and 73% of patients treated for cancer taking a dietary supplement (in particular phytotherapy) or a great heterogeneity according to the studies. however, there is still little evidence of the efficacy of these dietary supplements. a large proportion of patients do not seem to inform their doctor about the use of dietary supplements. patients using dietary supplements most often ignore the mode of action of these products and generally say they are not informed. in 2015, at the west cancerology institute (ico), 5 patient files were analyzed taking this type of treatment in addition to chemotherapy; in 2016, 24 files; 2017, 61 patient records and this continues to progress. at the same time, a product appears very frequently associated with cancer chemotherapy: desmodium adscendens, an african plant with in vitro properties of liver protector. the desmodium contains triterpene saponins, alkaloids, flavonoids, polyphenols, and tryptamine derivatives. morevover, several situations of patients undergoing chemotherapy and taking long-term desmodium, with hepatic cytolyses were experienced, not explained by the usual treatments (case described in the literature). therefore, this study will evaluate these new therapeutic modalities that are included in the intake of chemotherapy in order to better know them to improve the therapeutic taking of patients and to focus on the impact of desmodium in association with chemotherapy.

* determine the quantitative impact of the use of dietary supplements by patients with breast cancer and treated in a neo-adjuvant and/or adjuvant condition by iv chemotherapy in day hospital. * determine an over-risk of disruption of liver balance in the population of patients taking desmodium. * gather a critical mass of relevant information with the objective of carrying out the evaluation and analysis of cancer care practices related to the intake of dietary supplements.

Eligibility criteria:
inclusion criteria: * breast cancer treated by intra-venous chemotherapy * inclusion at the last cycle (cure) * all chemotherapy cycles realised at ico exclusion criteria: * no breast cancer * metastatic breast cancer * not all chemotherapy cycles realised at ico * patient who has not finished his chemotherapy

Keywords: dietary supplements desmodium chemotherapy breast cancer
physical deconditioning in covid-19 positive patients and non-specific low back pain

Conditions: Low Back Pain, Mechanical

Summary: the purpose of this study is to take advantage of cohorts of patients followed for coronavirus disease 2019 (covid19) expected to present poor physical fitness as the consequence of covid19 to explore the relationship between physical fitness and low back pain (lbp). level of physical fitness will be measured at baseline and incidence and intensity of lbp will be recoreded over 1 year.

non-specific low back pain (lbp) is the worldwide number one cause for disease related years lived with disability. it is frequently assumed that a low physical fitness is a major risk factor for acute lbp as well as a factor for chronic lbp. however only few prospective observational study have been conducted. the purpose of this study is to take advantage of cohorts of patients followed for coronavirus disease 2019 (covid19) expected to present poor physical fitness as the consequence of covid19 and assessing level of physical fitness and both incidence and intensity of lbp over a 1-year period. the study aims to determine if a poor physical health, as measured by 6 minutes walk test (6mwt) and 30''seconds sit to stand test (30''sts), is a risk factor for lbp occurrence and for chronic lbp secondary objectives aim to explore the respective weight of physical factors (i.e. physical fitness, bmi, smoking, physical activities) and psychological factors (i.e. depression, anxiety, catastrophism, fear-avoidance) on the occurrence and severity of lbp. according to the literature, we expect that in the physically healthy population, 15% will developed back pain; whereas in the population in poor physical health the incidence at 1 year will be 30%. if alpha error is set at 0.05 then 236 patients are required to have a 80% chance to confirm our hypothesis. in order to account for drop out, and considering that the risk of drop out is high in this type of non-interventional study 350 persons will be recruited. note that this amount of persons should yield approximately 70 persons with low back pain, which allow up to 7 independent variable in a logistic or cox regression. this is based on the rule of at least 10 events (low back pain) per variable.

Eligibility criteria:
inclusion criteria: * age \> 18 years, \<65 years old * confirmed or supected covid19 test * informed consent as documented by signature exclusion criteria: * inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant. * previous enrolment into the current study. * any comorbidity which could impact on the physical test (6-minutes walking test), e.g hip or knee osteoarthritis, polyneuropathy, symptomatic coronary heart disease.

Keywords: low back pain physical deconditioning chronicity
effect of yakult ingestion on diet-induced insulin resistance in humans

Conditions: Insulin Sensitivity; Insulin Resistance; Type 2 Diabetes Mellitus

Summary: participants will be randomly allocated to either yakult ingestion or a control group. for the first 20 days, subjects will consume their normal diet (keeping a detailed food diary throughout). on days 21-28 they will switch to a high-fat/high-calorie diet. the investigators hypothesise that consuming a high-fat, high-energy diet for 7 days will alter the composition of the gut microbiota and induce metabolic endotoxaemia / systemic inflammation as well as decreasing whole body insulin sensitivity (as we have shown previously). in contrast, the investigators hypothesise that consuming yakult for 21 days before and 7 days throughout the high-fat diet will maintain a favourable gut microbiota and prevent metabolic endotoxaemia / systemic inflammation and thus maintain insulin action / insulin sensitivity.


Eligibility criteria:
inclusion criteria: * males and females * aged 18-30 * physically active (exercising at least 3 times per week for more than 30 min at a time) * non-smoker * free from cardiovascular or metabolic disease * weight stable for at least 6 months * normal body mass index (bmi: 18.5-24.9 kg/m2)\* * compliant (i.e. understands and is willing, able and likely to comply with all study requirements) * note: if bmi is \>24.9, but body fat % (as measured by bioelectrical impedance analysis) is below 21% in males and 31% in females, then the subject may still be recruited at the pi's discretion. exclusion criteria: * using probiotic or prebiotic supplements within the previous 3 months * vegetarians and vegans * diagnosis of insulin resistance, pre-diabetes or full diabetes * underweight (determined as bmi less than 18.5 kg/m2) * overweight or obese (determined as bmi greater than 24.9 kg/m2) * those on a calorie controlled diet or other dietary restrictions that would prevent them from consuming the probiotic treatment and high fat/high calorie diet. * those who are unwilling to restrict their intake of fermented dairy products. * those with known or suspected food intolerances, allergies or hypersensitivity * women who are known to be pregnant or who are intending to become pregnant over the course of the study. * participation in another clinical trial * those who have donated blood within 3 months of the screening visit and participants for whom participation in this study would result in having donated more than 1500 ml of blood in the previous 12 months. * participants who take any form of regular medication that is known to affect either the gut microbiota and/or insulin sensitivity or who have taken any antibiotics in the previous 3 months. * participants who know they would not be available for all the lab visits during the 4-week study period.

Keywords: gut microbiota high fat diets probiotics glycaemic control
renal hemodynamic effects of the hmg-coa reductase inhibitors in normal volunteers and in patients with chronic renal failure

Conditions: Hyperlipidemia; Hypertension; Chronic Renal Failure

Summary: this study was done to determine whether simvastatin (a medication commonly used to treat patients with high cholesterol levels in the blood increases blood flow to the kidneys and improves renal function in normal volunteers and patients with impaired renal function secondary to polycystic kidney diseases.


Eligibility criteria:
patients with chronic renal failure: 1. age 18 or older 2. chronic renal failure secondary to autosomal dominant polycystic kidney disease 3. serum creatinine ≥ 1.4 but ≤ 2.0 mg/dl 4. creatinine or iothalamate clearance between 35-70 ml/min per 1.73m2 5. stable renal function for the three preceding months 6. blood pressure needs to be adequately controlled (\< 140/90 mm hg), with or without the use of antihypertensive agents. however, ace inhibitors or at1 receptor blockers must not be initiated, or have their dose increased during the study period. patients with normal renal function: 1. age 18 or older 2. normal renal function and diagnosed with autosomal dominant polycystic kidney disease 3. serum creatinine ≤ 1.4 4. creatinine or iothalamate clearance ≥70 ml/min per 1.73m2 5. renal function has to be stable for the three preceding months 6. blood pressure needs to be adequately controlled (\< 140/90 mm hg), with or without the use of antihypertensive agents. however, ace inhibitors or at1 receptor blockers must not be initiated, or have their dose increased during the study period. exclusion criteria include: 1. patients using corticosteroids, cytotoxic drugs (alkylating agents, chlorambucil, cyclophosphamide), cellcept, or cyclosporin a therapy 2. positive hepatitis b surface antigen (hbsag) or hepatitis c antibody (hcv-ab) 3. serum transaminase levels (ast, alt) 2 times the upper limit of normal 4. clinically significant medical conditions 5. pregnant patients, patients who are breast-feeding, or women intending to conceive during the course of the study 6. presence or suspicion of active infection, recent serious infection or chronic/recurrent viral or bacterial infection 7. presence of concomitant renal artery stenosis.
perioperative management of preoperative anemia in colorectal cancer

Conditions: Anemia; Colorectal Cancer

Summary: both preoperative anemia (pa) and perioperative blood transfusion can contribute on poorer outcomes after colon cancer surgery. anemia is known to be associated with a slower recovery after surgery thus often worsening short-term results, and allogenic red blood cells transfusion (arbt) are known to promote systemic inflammatory response and affect overall and cancer-specific survival. patient blood management (pbm) systems are an evidence-based multimodal approach focused on safe and rational use of blood products, mainly through a proper pa assessment, a minimization of procedural blood loos and strict transfusion policies. given the high prevalence of pa in patients with colorectal cancer (crc), and its association with adverse events, it is expected that pbm implementation in said scenario carries a decrease in complications and an improved survival rate. available literature to date supports preoperative anaemia screening and restrictive transfusion policies, nevertheless barriers exist that limit the expected implementation of pbm systems in colorectal surgery. the present study aims to evaluate feasibility of a pbm pathway implementation in a high-volume crc surgery unit based on completion of anemia screening and treatment before surgery and changes of allogenic products use along the years. the objective is to estimate the impact of a proper preoperative optimization with iron intravenous infusion (ivi) on pa measured from changes hemoglobin (hb) levels in comparison to those of non-anemic patients.


Eligibility criteria:
inclusion criteria: * patients diagnosed with colorectal cancer * patients with an indication of elective radical surgery exclusion criteria: * treatment with red blood cells transfusion before assessment in the pbm anemia clinic * non-iron deficient anemia * treatment with sucrose-based ivi or oral iron (oi) preparations not strictly controlled by the pbm clinic

Keywords: anemia colorectal cancer intravenous iron therapy transfusion patient blood management
effectiveness of estradiol valerate pretreatment in antagonist protocol for poor ovarian response patient

Conditions: Infertility

Summary: the purpose of study is to assess the efficacy of add-on estrogen pretreatment in gnrh antagonist protocol on oocyte retrieval as compared with gnrh antagonist protocol for patients with poor ovarian response add-on estrogen pretreatment protocol is superior to none pretreatment gnrh antagonist protocol for the number of oocytes retrieval

women of advanced maternal age seeking art treatment are characterized as poor ovarian responders in the process of ovarian simulation. poor response to ovarian stimulation causes high cycle cancellation rate and extremely low pregnancy rate. more attention has been paid to the potential interest of steroid pretreatments in gnrh antagonist cycles; not only for scheduling the gnrh antagonist cycles, but also for synchronizing the follicular growth which may result in more oocytes retrieved. but available clinical results are controversial. previous studies have shown that utilizing the natural negative feedback of the hypothalamus-pituitary-ovary axis induced by estradiol valerate pretreatment effectively prevented inter-cycle increases in follicle-stimulating hormone, improved follicle synchronization, and resulted in a more coordinated follicular development, leading to the recovery of more mature oocytes. however none of the randomized controlled studies compared estradiol valerate pretreatment or not on treatment outcomes, ongoing pregnancy rate, directly on poor response patients using estradiol valerate pretreatment in gnrh antagonist protocol.

Eligibility criteria:
inclusion criteria:bologna criteria * at least two of the following three features must be present: 1. advanced maternal age (≥40 years) or any other risk factor for por 2. a previous por (≤3 oocytes with a conventional stimulation protocol) 3. an abnormal ovarian reserve test (i.e. antral follicle count \< 5-7 follicles or amh\< 0.5 - 1.1 ng/ml) exclusion criteria: 1. age ≥45 years, 2. patients who conducted pgd/pgs, and donor egg cycles were excluded. 3. presence of unilateral ovary absence 4. abnormal uterine deformity or structure. 5. spontaneous abortion patients with three or more (including biochemical pregnancy abortion) 6. with other endocrine disease, ovulation disorders such as adrenal cortex function or thyroid dysfunction 7. have assisted reproductive technology contraindications or pregnancy contraindication of patients

Keywords: gnrh antagonist estrogen pretreatment poor response patient